I cover cardiology news for CardioExchange, a social media website for cardiologists published by the New England Journal of Medicine. I was the editor of TheHeart.Org from its inception in 1999 until December 2008. Following the purchase of TheHeart.Org by WebMD in 2005, I became the editorial director of WebMD professional news, encompassing TheHeart.Org and Medscape Medical News. Prior to joining TheHeart.Org, I was a freelance medical journalist and wrote for a wide variety of medical and computer publications. In 1994-1995 I was a Knight Science Journalism Fellow at MIT. I have a PhD in English from SUNY Buffalo, and I drove a taxicab in New York City before embarking on a career in medical journalism. You can follow me on Twitter at: @cardiobrief.

Live Blog-- FDA Advisory Panel on Rivaroxaban (Xarelto)

9:53– Califf criticizes FDA for comparing ROCKET to RE-LY and not mentioning that RE-LY was not double blinded.

9:49– I’m really curious to see how the FDA will respond to Califf’s withering dissection of the importance of TTR. Califf wins this years edition of “So You Think You Can Dance.” He can dance.

9:42– TTR in ROCKET in North America as good as other trials, especially when taking into account the severity of illness. Regional differences therefore account for difference in TTR. In the US TTR in ROCKET was actually better than common practice.

9:33– Califf uses a slide about TTR from panel member Fleming, but promises that they chose the slide before they knew he would be on the panel. Califf says TTR can be a “useful measure of quality improvement” but not a “useful surrogate.” I’m confused.

9:33– Califf uses a slide about TTR from panel member Fleming, but promises that they chose the slide before they knew he would be on the panel.

9:32– “I would be lying to you” if I said the executive committee wasn’t concerned when they first saw the TTR results.

9:30– In the US where TTR was high the treatment effect was better for rivaroxaban. Despite lower TTR rate in ROCKET, results are similar to RE-LY and ARISTOTLE.

9:26– Now we get to the heart of the issue: TTR. Califf says he won’t bash the FDA but watch out… We found no relationship between center TTR and efficacy. The major trials don’t show that TTR predicts efficacy.

9:26– Now we get to the heart of the issue: TTR. Califf says he won’t bash the FDA but watch out…

9:22– Califf agrees there is a problem (but very small numbers) with patients discontinuing R at the end of the trial. He says the recommendation to maintain continuous anticoagulation and to keep patients on R until the INR on warfarin is acceptable, but he admits there is no clinical trial data to support this. Califf also notes that we don’t know what to do when discontinuing dabigatran. ”We’re not unique in this regard in basing our discontinuation strategy on PK data.” We shouldn’t be held at a higher standard than other drugs.

9:19– Now Califf is addressing the problem of higher risk after patients discontinue R and transition to warfarin or other VKA (vitamin K antagonist).

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